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KMID : 1142220180130010069
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Regulatory Research on Food, Drug & Cosmetic
2018 Volume.13 No. 1 p.69 ~ p.75
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A Study on Development of Guideline to Establish Performance Evaluation for the IVD reagents for urine chemistry
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Lee Seung-Ro
Kim Ji-Eun
Kim Bo-Ra
Lim Chun-Il
Kim Mi-Jeong
Seo Kyung-Won
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Abstract
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IVD reagents for urine chemistry is used for the chemical test of urine which is one of the secretions of the body. It is used for urine reagent strip to detect about 10 kinds of test items. As the life span is longer, kidney disease, diabetes and other kidney-related diseases are increasing, and the demand for early diagnosis and prevention is growing not limited to the treatment of diseases. As a result, the demand for urine reagent strips are also steadily increasing. Urinalysis using urine reagent strip is a primary screening test at medical institutions and health screenings, and plays an important role in the medical field. So it is essential to ensure the reliability of the products. In this study, we developed performance evaluation methods of urine reagent strip used the most frequently among in vitro diagnostic medical devices and suggest a guideline. First of all, we investigated the current domestic and international status of registration, class and authorization methods, then, analyzed standards and guidelines related to urine reagent strip test. Based on these, the performance evaluation items and methods were derived, and that tested to verify. Finally, we prepared performance evaluation guidelines for urine regent strip. The performance evaluation test methods of urine reagent strip developed through this study is expected to contribute strengthening the competitiveness of domestic medical device industry by being utilized as references of medical device manufacturers, researchers and medical device inspection institutions.
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KEYWORD
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urine reagent strip test, urinalysis, In-vitro Diagnostics, performance evaluation
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